---
title: Efficacy of 5-fluorouracil and Low Molecular Weight Heparin in High-risk Pediatric Retinal Detachment
nct_id: NCT06166914
overall_status: COMPLETED
phase: NA
sponsor: Alexandria University
study_type: INTERVENTIONAL
primary_condition: Retinal Detachment
countries: Egypt
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06166914.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06166914"
ct_last_update_post_date: 2023-12-19
last_seen_at: "2026-05-12T07:27:07.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Efficacy of 5-fluorouracil and Low Molecular Weight Heparin in High-risk Pediatric Retinal Detachment

**Official Title:** Evaluation of 5-fluorouracil and Low Molecular Weight Heparin Intraoperative Infusion in Preventing Proliferative Vitreoretinopathy in High Risk Pediatric Rhegmatogenous Retinal Detachment

**NCT ID:** [NCT06166914](https://clinicaltrials.gov/study/NCT06166914)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 42
- **Lead Sponsor:** Alexandria University
- **Conditions:** Retinal Detachment, Proliferative Vitreoretinopathy
- **Start Date:** 2021-10-21
- **Completion Date:** 2023-05-21
- **CT.gov Last Update:** 2023-12-19

## Brief Summary

EVALUATION OF 5-FLOUROURACIL AND LOW MOLECULAR WEIGHT HEPARIN INTRAOPERATIVE INFUSION IN PREVENTING PROLIFERATIVE VITREORETINOPATHY IN HIGH RISK PEDIATRIC RHEGMATOGENOUS RETINAL DETACHMENT

## Detailed Description

After informed consent, children under 14 years of age with high-risk PRRD underwent pars plana vitrectomy and silicone oil injection with scleral buckle divided into 2 groups in prospective randomized trial. Group A received intraoperative infusion of 5-FU (200 µg/ml) and LMWH (5 IU/ml), group B received infusion of normal saline. Primary outcome was occurrence of recurrent PRRD within 12 weeks, secondary outcomes were occurrence of PVR, best corrected visual acuity (BCVA), number and timing of secondary procedures within 12 weeks.

## Eligibility

- **Minimum age:** 0 Years
- **Maximum age:** 14 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

Children under 14 years of age with RRD undergoing primary repair Preoperative PVR grade B or higher High risk RRD: uveitis; large, giant, or multiple tears; vitreous hemorrhage; preoperative choroidal detachments; aphakia; and large detachments involving greater than two quadrants of the eye

Exclusion Criteria:

Children with RRD related to penetrating ocular trauma involving the posterior segment Previous RD repair surgery Uncontrolled glaucoma or other concomitant ocular morbidities Patients with bleeding diathesis, hepatic and renal failure Corneal opacity sufficient to impair surgical view No light perception vision Inability to complete follow-up
```

## Arms

- **Treatment group** (EXPERIMENTAL) — Group A received intraoperative infusion of 5-FU (200 µg/ml) and LMWH (5 IU/ml) during pars plana vitrectomy and silicone oil injection with scleral buckle in children under 14 years of age with high-risk PRRD
- **Control group** (PLACEBO_COMPARATOR) — Group B received infusion of normal saline during pars plana vitrectomy and silicone oil injection with scleral buckle in children under 14 years of age with high-risk PRRD

## Interventions

- **Intraoperative infusion of 5-FU (200 µg/ml) and LMWH (5 IU/ml)** (DRUG) — After informed consent, children under 14 years of age with high-risk PRRD underwent pars plana vitrectomy and silicone oil injection with scleral buckle divided into 2 groups in prospective randomized trial. Group A received intraoperative infusion of 5-FU (200 µg/ml) and LMWH (5 IU/ml).
- **Placebo** (DRUG) — After informed consent, children under 14 years of age with high-risk PRRD underwent pars plana vitrectomy and silicone oil injection with scleral buckle divided into 2 groups in prospective randomized trial. Group B received infusion of normal saline.

## Primary Outcomes

- **Recurrent RD due to PVR** _(time frame: 12 weeks post operative)_ — Clinical retinal detachment with any grade PVR

## Secondary Outcomes

- **Post operative PVR** _(time frame: 12 weeks post operative)_
- **Best corrected visual acuity** _(time frame: 12 weeks post operative)_
- **Secondary procedures** _(time frame: 12 weeks post operative)_

## Locations (1)

- Faculty of Medicine, Alexandria University, Alexandria, Egypt

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.faculty of medicine, alexandria university|alexandria||egypt` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06166914.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06166914*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*